Review Process

The IRB committee consists of at least five faculty members appointed by the Provost; a member of the community unaffiliated with the College, also appointed by the Provost; and, serving ex officio, the College Counsel, the Director of Sponsored Research, and the Grants Associate.

Faculty members, staff members, or students who are planning research projects involving human participants are responsible for initiating the review process by submitting their research proposals to the faculty member in their department who has been designated as the "departmental reviewer." (Each department and the Graduate School of Social Work and Social Research should appoint a faculty member as the "departmental reviewer" who will be responsible for overseeing this initial review.) The departmental reviewer, a representative of the IRB, reviews the proposed research, determines whether the proposal is exempt from further review or requires an expedited or full review, and confirms that the application is complete.

All research proposals are evaluated by the departmental reviewer, the chair of the IRB, or the full IRB committee with regard to the degree of "risk," if any, to human participants. The IRB will provide the departmental reviewer with a set of forms to aid in the determination of risk.

Research in the exempt category requires a confirmation of exemption by the IRB chair. Exemption means that there is no risk to participants. The departmental reviewer should send research that is deemed exempt to the IRB chair via email. The IRB chair will confirm the level of review and then send a letter to the researcher confirming the exemption. At that point, unless procedures change, there is no further review by the IRB. (See Form B, which defines the categories of research that are exempt.)

Proposals determined by the departmental reviewer to require expedited review will be forwarded to the chair of the IRB, who will designate a member of the IRB (who remains anonymous to the researcher) to conduct the review. Expedited review means that the study poses no more than minimal risk. The proposed research must involve no more than minimal risk and the only involvement of human participants must fall under one or more categories, specified under Expedited Review (See Form C, which defines the categories of research requiring an expedited review).

Full committee review is required when the procedures of the research present more than minimal risk to the subject and/or fall into one or more of the categories specified under Full Committee Review (See Form D, which defines the categories of research requiring a full review). Proposals judged by the departmental reviewer to require full review will be forwarded to the chair of the IRB. The Chair will forward the proposal to the IRB committee as a whole, which will then perform the review.

Research requiring full reviews are reviewed at 4 full IRB meetings during the academic year, in October, December, February, and May. The specific meeting dates are posted at the beginning of each semester.

It is expected that most research projects will fall into the exempt or expedited categories.

There are three possible outcomes to a review:

Approved -- no further action is required from the investigator prior to initiating the study;

Revise and Resubmit -- more extensive changes are required before the study may begin;

Denied – the proposed research, because of the level of risk involved, cannot be initiated. (This is a rare occurrence. The IRB works with the investigator to modify research procedures to facilitate approval.)

Research approved by the IRB that is continuing must be re-reviewed on an annual basis in one of the four stated meetings of the IRB which is closest to the anniversary of the proposal’s original approval.

A letter describing the decision of the IRB committee will be sent to the investigator. Faculty members, staff members, or students who have submitted research proposals for review and have been asked to make revisions or have been denied approval may request the IRB to review its decision, and may write to or appear before the committee to discuss that decision.

The IRB committee will meet twice each semester (October, December, February, and May), with dates designated and circulated to all members of the faculty before the beginning of each semester. Research proposals requiring full review should be submitted at least one week before the committee meeting. Remember that the Departmental Reviewer has to sign off on the full review application before it is sent to the IRB chair, one week in advance of the meeting. Any proposal in need of full review that does not meet this deadline will be reviewed during the next scheduled meeting. If the changes requested for a full review are minor, the IRB chair can review the changes and it does not need to go to the IRB committee. If changes are substantial, they will be reviewed at the next stated meeting of the IRB. Research proposals in need of exempt or expedited review may be sent to the chair of the IRB at any time.

Departmental review timetables are left to the discretion of the departments and their reviewers. The IRB is available as an advisory board if there are any questions regarding the review process and categories of review.